Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HAMMERLOC TM TIBIAL FIXATION DEVICE

K-Number: K103145 · 2011-02-09

ApplicantBiomet Sports Medicine
Decision Date2011-02-09
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HAMMERLOC TM TIBIAL FIXATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Sports Medicine. It received FDA 510(k) clearance on 2011-02-09 under 510(k) number K103145. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAMMERLOC TM TIBIAL FIXATION DEVICE?

HAMMERLOC TM TIBIAL FIXATION DEVICE is a medical device that received FDA 510(k) clearance on 2011-02-09. The listed applicant is Biomet Sports Medicine. The 510(k) number is K103145.

When did HAMMERLOC TM TIBIAL FIXATION DEVICE receive FDA 510(k) clearance?

HAMMERLOC TM TIBIAL FIXATION DEVICE received FDA 510(k) clearance on 2011-02-09, under 510(k) number K103145.

Who is the listed applicant for HAMMERLOC TM TIBIAL FIXATION DEVICE?

The FDA 510(k) record lists Biomet Sports Medicine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HAMMERLOC TM TIBIAL FIXATION DEVICE?

The FDA product code for HAMMERLOC TM TIBIAL FIXATION DEVICE is MBI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biomet Sports Medicine as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K122437NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERSK123485JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOFK110879BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHORK111564MAXFIRE MARXMEN MENISCAL REPAIR DEVICEK110039BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEMK101063SLEEVE WITH ZIPLOOP FIXATION DEVICES

View all 8 devices →

Related Devices (Code: MBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑